MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-03 for HOLLOW GOUGE FOR BROKEN SCREW EXPOSURE 399.68 manufactured by Synthes Salzburg.
[52395343]
Device was used for treatment, not diagnosis. Device is an instrument and is not implanted/explanted. (b)(6). Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system. A device history record review was performed for the subject: manufacturing location: (b)(4). Manufacturing date: 31. March 2013. No anomalies were detected during device history record review. No ncrs were generated during production. Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[52395344]
Device report from synthes on an event in (b)(6) as follows: it was reported that during the hardware removal surgery, the gouge was being used as intended to expose the fragment of broken screw (manufacturer unknown) and the handle of the hollow gouge for broken screw exposure broke away from the gouge. No piece of the broken device fell inside the patient. Spare device was readily available to complete the procedure. There was 2 minutes surgical delay due to the reported event. This complaint involves 1 device. This report is 1 of 1 for com-(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[55355307]
Product investigation summary: this complaint is confirmed as the device was received in a broken condition. However, the handle is not broken as reported; instead the tip of the gouge is actually broken off (the corner of the tip of the gouge is broken off, not the handle). Whether this complaint can be replicated is not applicable as the device is already broke. Upon visual inspection of the complaint device, the complaint description has been confirmed. A portion of the distal tip of the device has sheared off. The sheared off portion would be approximately 9mm long by 4mm wide as measured with reference to the relevant drawing. The balance of the device is in good condition with minor wear consistent with use. A root cause could not be determined for this complaint; most likely the instrument has been in the field for several years and went through multiple uses causing the complaint condition. The complaint category of "broken: procedural step unknown" was selected at complaint intake. Based on the complaint description, the failure mode of "broken: intraoperatively" will be selected for this investigation summary. No new, unique, or different patient harms were identified as a result of this evaluation. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. The returned gouge is part of the synthes screw removal set for removing synthes screws. The gouge is used to remove the bone surrounding the screw shaft prior to screw removal. A review of the current design drawing and the manufactured-to design drawing was performed. The design history was found to not impact the complaint condition. During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. A root cause could not be determined for this complaint; most likely the instrument has been in the field for several years and went through multiple uses causing the complaint condition. Patient information reported as? None? In error on the initial medwatch. The complained event had patient involvement, but the patient? S information is not available for reporting. The original awareness date of the complaint was reported as (b)(6) 2016 and (b)(4) 2016 in error on the initial medwatch. The actual awareness date of the event was (b)(6) 2016. Device used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009417901-2016-10025 |
| MDR Report Key | 5844668 |
| Date Received | 2016-08-03 |
| Date of Report | 2016-07-18 |
| Date Mfgr Received | 2016-09-09 |
| Device Manufacturer Date | 2013-03-31 |
| Date Added to Maude | 2016-08-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARK VORNHEDER |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES SALZBURG |
| Manufacturer Street | KAROLINGERSTRASSE |
| Manufacturer City | SALZBURG 5020 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | 5020 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOLLOW GOUGE FOR BROKEN SCREW EXPOSURE |
| Generic Name | GOUGE,SURGICAL,GEN & PLASTIC SURGERY |
| Product Code | GDH |
| Date Received | 2016-08-03 |
| Returned To Mfg | 2016-08-02 |
| Catalog Number | 399.68 |
| Lot Number | 5920988 |
| ID Number | (01)10886982203038(10)5920988 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES SALZBURG |
| Manufacturer Address | KAROLINGERSTRASSE SALZBURG 5020 AU 5020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-03 |